Joint DiseaseNCT03865667
Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Preserve Femoral Stem
An observational study of Joint Disease, run by MicroPort Orthopedics Inc. at 1 site in Spain.
Trial summary
MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) components marketed in the European Union (EU). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Joint Disease
- What is being tested?
- PROFEMUR® Preserve Femoral Stem
- Type of treatment
- Medical device
- How many people
- 63 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2019to 1 Jan 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Single-arm, single-center, prospective follow-up study with consecutively enrolled newly or previously implanted subjects with the PROFEMUR® Preserve Femoral Stem(s) and CoCr (cobalt-chromium) Modular Neck combined with other Wright Medical Technologies (WMT) or MPO (MicroPort) THA (Total Hip Arthroscopy) components including acetabular shells, acetabular liners and femoral heads.
Who may be able to join
None listed.
Who cannot join
- Subjects will be excluded if they meet any of the following criteria:
- Subjects implanted with non-MicroPort or Wright Medical Technology components (femoral heads, acetabular shells, acetabular liners);
- Subjects implanted with a PROFEMUR® Preserve stem assembled to a Titanium Modular Neck;
- Subjects skeletally immature (less than 21 years of age) at time of primary Total Hip Arthroscopy surgery;
- Subjects have or had an overt infection at the time of implantation;
- Subjects have or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation;
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- Subjects have or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at time of implantation;
- Subjects have or had inadequate neuromuscular status (e.g., prior paralysis, fusion and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable;
- Subject has neuropathic joints;
- Subject has hepatitis or HIV infection;
- Subject has a neurological or musculoskeletal disease that may adversely affect gait or weight-bearing;
- Subjects currently enrolled in another clinical study which could affect the endpoints of this protocol;
- Subjects unwilling or unable to sign the Informed Consent document;
- Subjects with documented substance abuse issues;
- Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study;
- Subjects who are incarcerated or have pending incarceration.
Trial locations and contacts
1 site in 1 country.
About this study
MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) components marketed in the European Union (EU). These types of studies are required by regulatory authorities for all THA devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in Europe. This study has been designed in accordance with the medial device directives (MEDDEV) 2.12/2 rev 2.
- Conditions
- Joint Disease
- Being tested
- PROFEMUR® Preserve Femoral Stem
- Medical subject headings
- Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROFEMUR® Preserve Femoral StemDevice
Total Hip Total Hip Arthroscopy
| Study group | Role | What they receive |
|---|---|---|
| Primary Total Hip Arthroplasty | Single-arm, single-center, prospective follow-up study with consecutively enrolled newly or previously implanted subjects with the PROFEMUR® Preserve Femoral Stem(s) and CoCr (cobalt-chromium) Modular Neck combined with other Wright Medical Technologies (WMT) or MPO (MicroPort) THA (Total Hip Arthroplasty) components including acetabular shells, acetabular liners and femoral heads. Receives: Device: PROFEMUR® Preserve Femoral Stem |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is to evaluate component survivorship of the PROFEMUR® Preserve Femoral Stem and CoCr Modular Neck out to 10 years follow-up.
Percentage of hips survived with no revision or replacement at 10-year.
Measured: 10 years
Secondary outcomes (4)
To determine the cumulative incidence of component revision of the PROFEMUR® Preserve Femoral Stem and CoCr Modular Neck at specified intervals out to 10 years follow-up.
Percentage of hips that were revised or replaced at each of the intervals namely for Early (2-5 years), midterm (5-7 Year), and long-term (10-year) evaluation.
Measured: Time Frame: 2-5 years, 5-7 years, and 10 years
To characterize functional scores, as assessed by Oxford Hip and EQ-5D-3L scores.
The study will be reporting the final Oxford Hip score, which is a summary over 12 items. Each of these items is 5-level Likert scale such as from 'not at all' to 'totally'. EQ-5D-3L data will be summarized over 5 domains, namely, mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each domain has 3 levels: no problems, some problems, and extreme problems.
Measured: Time Frame: 2-5 years, 5-7 years, and 10 years
To evaluate the presence and the zones of radiolucencies surrounding the implanted femoral components.
Radiolucencies are described around 7 zones and we will be reporting the number of hips with radiolucencies present at a given zone.
Measured: 2-5 years, 5-7 years, and 10 years
To characterize of adverse events and adverse device effects.
Adverse Events will be summarized as the total number of Adverse Events (AE), Adverse Device Effect (ADE) by grade, severity, and relationship to the device and surgery. Number of patients experiencing such AEs and ADEs will be also provided.
Measured: 2-5 years, 5-7 years, and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start15 Jan 2019
- Primary completion1 Jan 2032 (estimated)
- Study completion1 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint DiseaseStudies of the same condition, open and under way.
- More trials run by MicroPort Orthopedics Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- MicroPort Orthopedics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Manel Ribas, MD, Principal investigator, Hospital Universitari Dexeus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865667
- Sponsor's protocol ID
- 12-LJH-002G
- Status last verified
- Apr 2023
- First submitted
- 4 Mar 2019
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Preserve Femoral Stem
- ClinicalTrials.gov ID
- NCT03865667
- Acronym / sponsor ID
- 12-LJH-002G
- Conditions
- Joint Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 63 participants (actual)
- Lead sponsor
- MicroPort Orthopedics Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 1 Jan 2032 (estimated)
- Study completion
- 1 Jan 2032 (estimated)
- First posted
- 7 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) components marketed in the European Union (EU). These types of studies are required by regulatory authorities for all THA devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in Europe. This study has been designed in accordance with the medial device directives (MEDDEV) 2.12/2 rev 2.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary Total Hip Arthroplasty | – | Device: PROFEMUR® Preserve Femoral StemSingle-arm, single-center, prospective follow-up study with consecutively enrolled newly or previously implanted subjects with the PROFEMUR® Preserve Femoral Stem(s) and CoCr (cobalt-chromium) Modular Neck combined with other Wright Medical Technologies (WMT) or MPO (MicroPort) THA (Total Hip Arthroplasty) components including acetabular shells, acetabular liners and femoral heads. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Single-arm, single-center, prospective follow-up study with consecutively enrolled newly or previously implanted subjects with the PROFEMUR® Preserve Femoral Stem(s) and CoCr (cobalt-chromium) Modular Neck combined with other Wright Medical Technologies (WMT) or MPO (MicroPort) THA (Total Hip Arthroscopy) components including acetabular shells, acetabular liners and femoral heads.
Key inclusion criteria (0 listed)
Key exclusion criteria (16 listed)
- Subjects implanted with non-MicroPort or Wright Medical Technology components (femoral heads, acetabular shells, acetabular liners);
- Subjects implanted with a PROFEMUR® Preserve stem assembled to a Titanium Modular Neck;
- Subjects skeletally immature (less than 21 years of age) at time of primary Total Hip Arthroscopy surgery;
- Subjects have or had an overt infection at the time of implantation;
- Subjects have or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PROFEMUR® Preserve Femoral StemTotal Hip Total Hip Arthroscopy | Device | Primary Total Hip Arthroplasty |
Primary outcome
The primary endpoint is to evaluate component survivorship of the PROFEMUR® Preserve Femoral Stem and CoCr Modular Neck out to 10 years follow-up.
Time frame: 10 years
Percentage of hips survived with no revision or replacement at 10-year.
4 secondary outcomes
To determine the cumulative incidence of component revision of the PROFEMUR® Preserve Femoral Stem and CoCr Modular Neck at specified intervals out to 10 years follow-up.
Time frame: Time Frame: 2-5 years, 5-7 years, and 10 years
To characterize functional scores, as assessed by Oxford Hip and EQ-5D-3L scores.
Time frame: Time Frame: 2-5 years, 5-7 years, and 10 years
To evaluate the presence and the zones of radiolucencies surrounding the implanted femoral components.
Time frame: 2-5 years, 5-7 years, and 10 years
To characterize of adverse events and adverse device effects.
Time frame: 2-5 years, 5-7 years, and 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manel Ribas, MD principal investigator
Hospital Universitari Dexeus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Joint Disease, run by MicroPort Orthopedics Inc. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is to evaluate component survivorship of the PROFEMUR® Preserve Femoral Stem and CoCr Modular Neck out to 10 years follow-up. (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.